CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation

NCT00889265 | Completed Results

• 1 other identifier: 07-801
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible.

Conditions

Alveolar Ridge Defect

Keywords

Alveolar Bone Augmentation; Implant Surgery; Guided Bone Regeneration (GBR); Guided Tissue Regeneration (GTR); Bone Graft; Periodontal Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Horizontal Ridge Widths From Baseline to 6 Months

  The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.

  6 months

Secondary Outcomes (1)

• Mean Wound Healing Index at 6 Months

  6 months

Study Arms (1)

CopiOs Pericardium Membrane

EXPERIMENTAL

Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.

Device: CopiOs Pericardium Membrane

Interventions

CopiOs Pericardium Membrane DEVICE

CopiOs Pericardium, Puros Cancellous

Also known as: Pericardium Membrane, Bovine Xenograft, Cancellous Particulate, Human Allograft

CopiOs Pericardium Membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, of any ethnicity, between 18 and 99 years of age
• Health status of P1(ASA I) or P2 (ASA II), as classified by the American Academy of Anesthesiologists
• Able to communicate with the investigator and read, understand, and sign the informed consent form
• No evidence of active moderate or severe periodontitis
• Must be available for multiple follow-up visits for the duration of the study
• The study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5 mm in its smallest buccolingual dimension as measured by ridge-mapping calipers (#RIDGE-CALIPER, Salvin Dental Specialties, Inc., Charlotte, NC).

You may not qualify if:

• Inability or failure to maintain adequate oral hygiene
• Women who are bread-feeding, pregnant, or who intend to become pregnant during this study period. Women of childbearing potential should be practicing a medically accepted method of birth control
• Patients with unstable systemic diseases
• Patients with compromised immune system (e.g. uncontrolled diabetes, etc.) or unstable bleeding disorder
• Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HEV, etc.)
• Patients with a mental disability that may hinder participation in the study (e.g. inability to follow through with oral hygiene instructions, postoperative instructions, follow-up commitments, etc.)
• Patients taking steroid medications or undergoing other immunosuppressive therapy
• Radiation, cancer therapy, and/or radiation specifically at the oral cavity within the last 6 months
• History of previous ridge augmentation at the site of interest
• Augmentation sites with localized pathology
• Patient who has participated in a clinical trial within 30 days of being enrolled in this study, is currently enrolled in another study, or plans to enroll in another study before the completion of of this study.
• Unresolved oral pathologies (e.g. periodontal disease, caries, etc.)
• Medications or conditions contraindicated for bone regeneration: methotrexate, corticosteroids, history of bisphosphonate use, cyclosporine-A, etc.
• Patients who have more than a minimal tobacco use (e.g. \>10 cigarettes per day)
• Other conditions the investigator may feel would inhibit the patient from being a good candidate for this study or which are contraindicated in the Directions for Use.

Sponsors & Collaborators

• Zimmer Biomet: lead
• Zimmer Dental: collaborator

Study Sites (4)

University of Colorado Denver School of Dental Medicine

Aurora, Colorado, 80045, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Texas Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Sciences Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Results Point of Contact

• Title: Dr Hai Bo Wen, Director of Research
• Organization: Zimmer Dental

haibo.wen@zimmer.com

760-929-4312

Study Officials

• Brian Mealy

  University of Texas Health Sciences Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2009
• First Posted: April 28, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 11, 2014
• Results First Posted: August 7, 2014

Record last verified: 2014-08

Locations

US (4)